Pharmaton Vitality Capsules

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients		Declaration capsule	per
G115 Panax Ginseng extract [dry extract ethanolic 40%: 1.3 - 3:1]		40.0	mg
Vitamin A Palmitate	(Vit.A)	2667	IU
Colecalciferol	(Vit.D3)	200	IU
D,L-a-Tocopherol acetate	(Vit.E)	10	mg
Thiamine mononitrate	(Vit.Bl)	1.4	mg
Riboflavin	(Vit.B2)	1.6	mg
Pyridoxine hydrochloride	(Vit.B6)	2.0	mg
Cyanocobalamine	(Vit.B12)	1.0	mcg
Biotin		150.0	mcg
Nicotinamide		18.0	mg
Ascorbic acid		60.0	mg
Folic acid		0.1	mg
Copper(II) sulfate dried	(Cu:2.0 mg)	5.6	mg
Sodium selenite, dried	(Se:50.0 mcg)	111.0	mcg
Magnesium sulfate, dried	(Mg:10.0 mg)	71.0	mg
Iron(II) sulfate, dried	(Fe:10.0 mg)	33.0	mg
Zinc sulfate, monohydrate	(Zn:1.0 mg)	2.75	mg
Dibasic calcium phosphate, anhydrous	(Ca:100.0 mg)	340.0	mg
Lecithin (containing choline, inositol, linoleic acid, linolenic acid)		100.0	mg

3. PHARMACEUTICAL FORM

Soft gelatin capsules for oral use.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Pharmaton Vitality Capsules contain vitamins, minerals and standardised Ginseng Extract G115 in amounts which suit the body's daily requirements.

The capsules are indicated for relief of temporary periods of:

States of exhaustion (e.g. caused by stress), tiredness, feeling of weakness, vitality deficiency.

Prevention and treatment of symptoms caused by ill-balanced or deficient nutrition.

4.2 Posology and method of administration

For situations of short term tiredness and exhaustion, Pharmaton Vitality Capsules are recommended for 4 weeks. If symptoms have not shown any improvement after 4 weeks, consult a doctor. Pharmaton Vitality Capsules may be taken for periods of up to 12 weeks. For longer term use consult a doctor.

Adults: The recommended daily dosage is one capsule per day .

The capsule should preferably be taken in the morning with food.

Children: Not recommended for use in children.

Elderly: There are no special dosage recommendations for the elderly.

4.3 Contraindications

Pharmaton Vitality Capsules are contraindicated in patients with disturbances of calcium metabolism (e.g. hypercalcaemia and hypercalciuria), hypervitaminosis A or D, renal insufficiency, concomitant retinoid (e.g. for acne) or vitamin D therapy, haemochromatosis, iron overload syndrome and in patients with known hypersensitivity to any of the ingredients in the product.

Pharmaton Vitality Capsules contain arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Pharmaton Vitality Capsules.

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions for use”), the use of the product is contraindicated.

4.4 Special warnings and precautions for use

Patients with a family history of haemochromatosis should seek medical advice before taking Pharmaton Capsules.

An allowance should be made for vitamins or minerals obtained from other sources.

In states of exhaustion (e.g. caused by stress), clinical trials have shown that improvement starts usually within 4 weeks of treatment. If symptoms have not shown any improvement during that time, or you are concerned, please consult your doctor.

The label will state “Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal”. This will appear on the labelling within a rectangle in which there is no other information.

Patients taking warfarin (or other coumarin anticoagulants) should have increased monitoring of their INR levels when starting or stopping treatment with ginseng containing products.

Each capsule contains a small amount of lactose (26 mg). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

In case of concomitant intake of ginseng preparations and anticoagulants, the effect of oral blood thinning medication (e.g. warfarin) may potentially be reduced. Patients on blood thinning medications should seek medical advice before starting this product.

Interactions of iron with tetracycline antibiotics (tetracycline, doxycline, minocycline) and vitamin B₆ and levodopa are known. Patients on any of these medications should seek medical advice before starting this product.

4.6 Fertility, pregnancy and lactation

Pregnancy and lactation

Reproduction studies with animals using the standardized Panax ginseng extract G115 Pharmaton showed no teratogenic effects. However, controlled studies with pregnant women are not available.

Controlled studies with women using multivitamin-mineral preparations at the usual dosage during the course of the first trimester resulted in no fetal risks. There are no signs indicating a risk if this type of preparation is taken during the second and third trimesters, and the probability of injuring the fetus appears to be very low.

Large doses of vitamin A (10,000 IU per day) have been found to be teratogenic if administered during the first trimester of pregnancy. Vitamin D given during the last trimester of pregnancy may cause hypercalcaemia in infants. As with many other medicines an assessment of benefits versus risks should be made before this product is administered during this period.

Pharmaton Vitality Capsules should not be taken during pregnancy or lactation. Fertility

No studies on the effect on human fertility have been conducted with Pharmaton Vitality Capsules.

Reproduction studies with animals using the standardized Panax ginseng extract G115 Pharmaton showed no adverse effects on fertility.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Adverse events have been ranked under headings of frequency using the following convention:

Very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1000, <1/100); rare (> 1/10000, <1/1000); very rare (<1/10000); not known - cannot be estimated from the available data.

Immune system disorders:

Not known: hypersensitivity

Nervous system disorders:

Common: headache Not known: dizziness

Gastro-intestinal disorders:

Common: nausea, vomiting Uncommon: diarrhoea Not known: abdominal pain

Skin and subcutaneous tissue disorders:

Not known: rash, pruritus

Psychiatric disorders Not known: insomnia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Nervousness may occur following an overdose of the product.

The toxicity of the product in large overdoses is caused by the toxicity of the liposoluble vitamins A and D. A safe dose for both vitamins is considered to be 5-10 x RDA (each capsule contains the EU %RDA for vitamins A and D).

Prolonged supply of larger amounts (40-55 x RDA for Vitamin A; 10-25 x RDA for Vitamin D) can cause symptoms of chronic toxicity. Acute toxic symptoms are only seen at even higher doses.

Iron: Severe acute toxicity in man has been reported from doses of iron ranging from 121500 x RDA (each capsule contains the UK %RDA for iron). Most incidents of acute iron toxicity have resulted from accidental oral ingestion of iron pills by children. Longer-term doses of iron up to 6-7 x RDA have been reported to have no toxic effect.

Symptoms: Initial symptoms include nausea, vomiting, diarrhoea, abdominal pain,

haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and

metabolic acidosis may also occur.

Treatment: To minimise or prevent further absorption of the medication, as follows:

• Induce vomiting e.g. by administration of an emetic

• Gastric lavage with desferrioxamine solution (2g/l). Then desferrioxamine (5 - 10g in 50-100ml water) should be introduced into the stomach to be retained.

• Severe poisoning: Shock and/or coma with high iron levels (serum iron >90pmol/l in children, >142pmol/l in adults); immediate supportive measures plus i.v. infusion of desferrioxamine should be instituted.

• Less severe poisoning: i.m. desferrioxamine is recommended (1g 4-6 hourly in children; 50mg/kg up to a maximum dose of 4g in adults).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmaton Vitality Capsules exert a stimulant effect at physical and psychological levels through the combined action of various substances on the basic metabolic processes.

The standardised ginseng extract G115 raises the general level of cellular activity, which is expressed by a pronounced increase in the physical and mental capacity.

In animal experiments, it caused a reduction of lactic acid concentration in muscles during exercise. An increase in the dopamine and noradrenaline content and a reduction in the serotonin content in the brain stem could be observed.

Vitamins, minerals and trace elements correct and prevent impairment of the cell metabolism in situations with increased demands. Low supply of vitamins, minerals, and trace elements may cause disturbances, such as debility, tiredness, decrease in vitality, reduced force of resistance, and decelerated convalescence. The composition and dosages of the preparation were chosen according to the European RDA-requirements for food supplements.

Choline, inositol, linoleic acid and linolenic acid, in the form of lecithin, improve energy output and lipid metabolism.

5.2 Pharmacokinetic properties

Pharmacokinetic studies of Pharmaton Vitality Capsules have not been carried out, because of the complex composition of the product and the small quantities of the active ingredients contained. Moreover, these substances are well known.

Pharmacokinetic studies of the standardised ginseng extract G115 are not possible, because it is a complex extract. In the ginseng root more than 200 substances have been identified to date. Pharmacokinetic studies of individual purified ginsenosides have been carried out in various animal species:

Using radioactively labelled (¹⁴C) Ginsenoside Rgl, originated from the standardized Panax ginseng extract G115 Pharmaton, a bioavailability of 30% was determined in mice.

With intraperitoneal application, depending on the tested animal species and the Ginsenoside type, a half-life of between 27 minutes and 14.5 hours was measured.

5.3. Pre-clinical Safety Data

Acute toxicity

The oral LD₅₀ of the standardized Panax ginseng extract G115 Pharmaton is more than 5 g/kg of body weight in the mouse and the rat, and more than 2 g/kg in the mini-pig.

Reproduction toxicity

The effect of standardized Panax ginseng extract G115 Pharmaton on reproductive performance was studied in two generations of Sprague-Dawley rats. Animals of both sexes were fed either control diet or diet supplemented with the standardized Panax ginseng extract G115 Pharmaton at dose levels of 1.5, 5 or 15 mg/kg body weight/day. Parameters of reproduction and lactation in the treated groups were comparable to those of the controls for two generations of dams and pups. No treatment-related effects were seen in weekly body weights and food consumption, haematological and blood chemistry parameters, and ophthalmic, macroscopic and histopathological examinations.

Fetal toxicity

The standardized Panax ginseng extract G115 Pharmaton, administered to pregnant Wistar rats and pregnant New Zealand rabbits, caused no abnormality in the foetal development.

The rats were treated with 40 mg/kg/day from the 1st to the 15 th day after mating.

The rabbits were treated with 20 mg/kg/day from the 7th to the 16th day after mating.

The fetuses were removed by caesarean section on the 21st day in the rats and on the 27th day in the rabbits.

6.1. List of Excipients

Capsule:

Rapeseed oil, refined Hard fat Ethyl vanillin Arachis oil (peanut oil) Triglycerides, medium chain Gelatin

Lactose monohydrate Silica, colloidal anhydrous

Capsule shell:

Gelatin Glycerol 85%

Iron oxide red (E172)

Iron oxide black (E172)

6.2 Incompatibilities

None stated.

6.3. Shelf-Life

Glass bottle packs 3 years

Blister packs 2 years

6.4. Special Precautions for Storage

Do not store above 25°C. Keep the container tightly closed.

6.5 Nature and contents of container

Brown glass bottles (hydrolytical class III, Ph.Eur) with pilfer proof aluminium caps (with rubber inserts) containing either 30, 40, 60, 90 or 100 capsules. Or Aluminium foil/polyvinylchloride/polyvinylidenchloride blister packs of 4, 30, 40, 60, 90 and 100 capsules.

Current Marketed Packs

Brown glass bottles (hydrolytical class m, Ph.Eur) with pilfer proof aluminium caps (with rubber inserts) containing either 30, 60, or 100 capsules.

6.6. Instructions for Use, Handling and Disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

8. MARKETING AUTHORISATION NUMBER(S)

PL 00015/0250

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

03/12/2008

10 DATE OF REVISION OF THE TEXT

28/04/2014